Clinical Regulatory Operations Publisher

  • Location
    Irvine, California
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Pharmaceutical - Clinical

Adecco Medical and Science has an immediate need for multiple Clinical Regulatory Operations Publishers for our Orange County location. The succesful candidates must have previous document and Records Management system and electronic publishing Experience with ICH, US, and EU Regulatory Requirements on all publishing formats (paper, NeeS, and eCTD) IND/NDA regulatory submissions.


Clinical Regulatory Operations Publisher


Job Summary:


The Regulatory Operations Publisher provides support to the Global Publishers, Publishing Managers, and Regulatory Product Mangers, regularly providing up to date status reports and reporting of issues in a timely manner. Primary responsibilities will require the submission specialist to understand current workload and ensure support to other publishers. Contributes to the production and distribution of study materials and site/study communications.

Essential Duties and Responsibilities:


· Create and assist with Virtual Document creation.
· Remediate pdf documents to be submission ready.
· Publish submissions, QC outputs to be submitted and submit via the corresponding
Gateway
Store submissions and acknowledgements in Document end Management System.
· Participate in other Regulatory Writing activities as required (e.g. Software upgrade testing,
Document reviews etc.)
· Ensure effective and standardized use and functionality of the regulatory submission
assembly and publishing systems, processes and tools.
· Perform Functional Administrator duties for RA eDoc systems, such as eCTD and eBLA, as necessary.
· Create folders on network file shares.
· Export or Import files, create Virtual Documents, add users and assign to groups.

Education and Experience:


· Working knowledge of IND/CTA, eNDA/eBLA, CTD submissions, XML document
management systems, regulatory databases, electronic labeling standards (PIM, SPL)
· Successful submission dossier experience in a regulated environment
· Experience in Document and Records Management system and electronic publishing
· Experience with ICH, US, and EU Regulatory Requirements on all publishing formats
(paper, NeeS, and eCTD)
· Experience with EXTEDO eCTD management and/or Veeva RIM software a plus

If you are interested in this Clinical Regulatory Operations Publisher job in Orance County, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at randy.williamson@adeccona.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_108175_330605